FDA says Low T Products must carry Blood Clot Warning

The U.S. Food and Drug androgel-bottleAdministration (FDA) announced on June 20, 2014 that Low T Products must carry blood clot warning information.

The agency announcement said Low T products must now warn on the label that Low T therapy drugs raise the risk of blood clots forming in the veins.

Testosterone therapy has been extensively and expensively advertised as a way to help aging men improve their sex lives and energy levels by raising what the advertisers call “Low T” levels. These products already do carry a warning about blood clots forming in the veins due to polycythemia, which is an unusual increase in the number of red blood cells that can occur with testosterone therapy treatments.

On June 20, the FDA said that reports of blood clots in the veins unrelated to polycythemia in patients taking testosterone products prompted it to now require a more general warning for venous blood clots on the labeling.

WebMD.com reports that “Blood clots in the veins include deep vein thrombosis (DVT) and pulmonary embolism, a potentially life-threatening event that occurs when a clot travels to the lungs.”

DVTs, clots most often found in the legs, have gained attention in recent years primarily due to clots forming in passengers after long-haul air flights, according to WebMD.

The FDA also said Friday that this latest warning about clots in the veins is unrelated to the agency’s ongoing investigations into stroke, heart attack and death risks of Low T therapy.

The FDA announced in Feb. 2014 that it would broadly review Low T therapy safety, after the agency saw studies which suggested Low T treatments might raise heart attack risks.

At that time the agency said in a press release that,  “FDA is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products. . . We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.”

The FDA also advised doctors to consider whether benefits of FDA-approved testosterone treatment were likely to exceed potential risks of Low T treatment.

Typically given by prescription or administered in gel, patch or injection form, Low T products are promoted in television and internet advertising. WebMD reports that Low T treatments have been marketed so well that Drugs.com reports via UCLA researchers that sales of Androgel exceeded those of blockbuster Viagra in 2013.

FDA has approved certain testosterone products only for use in men with low testosterone levels due to a medical condition such as genetic defects – ie. hypogonadism, the body’s inability to produce testosterone – or those with some other medical condition or genetic defect

Matthews & Associates is handling Low T injury cases across the country. Contact the firm for a free legal consultation if you or someone you love has suffered a heart attack or stroke or blood clotting or Deep Vein Thrombosis (DVT) after taking Low T therapy. The firm is filing Low T injury lawsuits across the country.

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